New Programme for Antenatal Preparation for Early Parenthood

NCT03679520 | Completed

• 1 other identifier: 2017/746
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 7

Brief Summary

Becoming a parent is a challenging stage in life, which provokes feelings of both excitement and insecurity; parents strive to develop confidence in their parenting role. Studies show that new parents often feel inadequately prepared for early parenthood which may have a negative impact on adjustment to life as a parent as well as health and wellbeing for the whole family. The overall aim is to develop, pilot test and evaluate a new programme for antenatal preparation for the early parenthood period. The hypothesis is that expectant first-time parents who receive an intervention with a new programme for antenatal preparation for parenthood will show higher scores for parental self-efficacy in the early parenthood period than those who do not receive the intervention. The specific aims for the pilot study are:

1. 1.To assess the acceptability of the procedures for parents and providers (midwives)
2. 2.To estimate the likely rates of recruitment and retention of participants
3. 3.To estimate the effects on outcome measurements in order to calculate the appropriate sample size in a full scale randomized controlled trial (RCT).

Conditions

Parents

Keywords

Prenatal education; Parents; Randomized controlled trial; Self Efficacy; Depression, postpartum

Outcome Measures

Primary Outcomes (1)

• The Parent Expectations Survey

  The Parent Expectation Survey (PES) will be used to assess parental self-efficacy. PES exists in two versions, one for prenatal use and one for postnatal use. Both versions contain 25 items with statements related to their perceived parental skills, the phrasing of the statements in the prenatal version is prefaced with "I will…" and in the postnatal version "I can…" otherwise the statements are identical. The statements are answered on 11-point Likert-type scales ranging from 0 (Cannot do) to 10 (Certain can do). Total score range 0-250. Higher scores indicate higher parental self-efficacy. Statistical comparison will be made to assess the change of parental self-efficacy (total score) across time, from baseline to postnatal follow-up, and groups.

  4 weeks postnatal

Secondary Outcomes (2)

• The Parents' Postnatal Sense of Security Instrument

  4 weeks postnatal

• The Edinburgh Postnatal Depression Scale

  4 weeks postnatal

Study Arms (2)

New programme

EXPERIMENTAL

A new programme of antenatal parental preparation provided by midwives to groups with 8-16 individuals. It will include 5 sessions á 2 hours and start in gestational week 25.

Other: New programme

Regular programme

ACTIVE COMPARATOR

A regular programme of antenatal parental preparation provided by midwives to groups of 8-16 individuals and encompassing between 5 and 7 hours of antenatal parental preparation.

Other: Regular programme

Interventions

New programme OTHER

Time for topics related to the time after birth and in reversed chronological order to give an early and joint focus on parenthood for both parents. Involving new parents to share their experiences of early parenthood with expectant parents. Introducing and using evidence-based websites in the sessions A breastfeeding preparation that gives tools to meet common challenges in the initial phase of breastfeeding. Based on principles for adult learning. Sessions 1. Introduction, life-change of becoming a parent and co-parenting 2. Early parenthood 3. Breastfeeding, caring for the baby and early parenthood 4. and 5 Labour, birth and postnatal care

New programme

Regular programme OTHER

Antenatal parental preparation "as usual". As no guidelines exist the number of sessions may vary between 2 and 3 sessions and smaller variations in content may also occur. Sessions 1. (or 1 and 2) Labour, birth and postnatal care 2. or 3 Breastfeeding, caring for the baby and early parenthood

Regular programme

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Expectant first-time parents
• Intention to participate in group based antenatal parental preparation
• Understand written and spoken Swedish

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (7)

Barnmorskemottagningen Dalby

Dalby, Sweden

Location

Barnmorskorna Mitt i Skåne

Höör, Sweden

Location

Barnmorskemottagningen Kävlinge

Kävlinge, Sweden

Location

Barnmorskemottagningen Knislinge

Knislinge, Sweden

Location

Barnmorskemottagningen Capio Singelgatan

Malmo, Sweden

Location

Barnmorskemottagningen Capio Västra hamnen

Malmo, Sweden

Location

Barnmorskemottagningen Granen

Malmo, Sweden

Location

Related Publications (11)

• Reece SM. The parent expectations survey: a measure of perceived self-efficacy. Clin Nurs Res. 1992 Nov;1(4):336-46. doi: 10.1177/105477389200100404.

  PMID: 1483137 BACKGROUND

• Persson EK, Fridlund B, Dykes AK. Parents' postnatal sense of security (PPSS): development of the PPSS instrument. Scand J Caring Sci. 2007 Mar;21(1):118-25. doi: 10.1111/j.1471-6712.2007.00442.x.

  PMID: 17428223 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• MRC (2006). Developing and evaluating complex interventions: new guidance. Medical Research Council. Available [2018-08-28] at https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/

  BACKGROUND

• Entsieh AA, Hallstrom IK. First-time parents' prenatal needs for early parenthood preparation-A systematic review and meta-synthesis of qualitative literature. Midwifery. 2016 Aug;39:1-11. doi: 10.1016/j.midw.2016.04.006. Epub 2016 Apr 28.

  PMID: 27321714 BACKGROUND

• Palsson P, Persson EK, Ekelin M, Kristensson Hallstrom I, Kvist LJ. First-time fathers experiences of their prenatal preparation in relation to challenges met in the early parenthood period: Implications for early parenthood preparation. Midwifery. 2017 Jul;50:86-92. doi: 10.1016/j.midw.2017.03.021. Epub 2017 Mar 31.

  PMID: 28399472 BACKGROUND

• Palsson P, Kvist LJ, Ekelin M, Hallstrom IK, Persson EK. "I Didn't Know What to Ask About": First-Time Mothers' Conceptions of Prenatal Preparation for the Early Parenthood Period. J Perinat Educ. 2018 Jun;27(3):163-174. doi: 10.1891/1058-1243.27.3.163.

  PMID: 30364409 BACKGROUND

• Feinberg ME. Coparenting and the transition to parenthood: a framework for prevention. Clin Child Fam Psychol Rev. 2002 Sep;5(3):173-95. doi: 10.1023/a:1019695015110.

  PMID: 12240706 BACKGROUND

• Bandura, A. (1997). Self-efficacy: the exercise of control. New York: W. H. Freeman and Company.

  BACKGROUND

• Barimani M, Vikstrom A, Rosander M, Forslund Frykedal K, Berlin A. Facilitating and inhibiting factors in transition to parenthood - ways in which health professionals can support parents. Scand J Caring Sci. 2017 Sep;31(3):537-546. doi: 10.1111/scs.12367. Epub 2017 Jan 31.

  PMID: 28144992 BACKGROUND

• Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.

  PMID: 17459542 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Linda J Kvist, PhD

  Lund University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Individual participant information will state that different ways of providing antenatal parental preparation will be evaluated, but will not reveal any specific information about the different types of antenatal parental preparation. Individual participants will therefore have no knowledge of allocation to control group or intervention group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Antenatal clinics randomised to control group provide antenatal parental preparation as usual (regular programme) to expectant parents and antenatal clinics randomised to intervention group provide a new programme of antenatal parental preparation to expectant parents.

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 20, 2018
• Study Start: September 3, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)